ESOMEPRAZOLE MAGNESIUM capsule, delayed release
esomeprazole magnesium by
Drug Labeling and Warnings
esomeprazole magnesium by is a Otc medication manufactured, distributed, or labeled by GLENMARK THERAPEUTICS INC., USA, Graviti Pharmaceuticals Private Limited. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredient
- Purpose
- Keep Out of Reach of Children
- Uses
-
Warnings
Allergy alert:
Do not use if you are allergic to esomeprazole.
Esomeprazole may cause severe skin reactions.
Symptoms may include:
- skin reddening
- blisters
- rash
If an allergic reaction occurs, stop use and seek medical help right away.
Do not use if you have
- trouble or pain swallowing food, vomiting with blood, or bloody or black stools
- heartburn with lightheadedness , sweating or dizziness
- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
- frequent chest pain
These may be signs of a serious condition. See your doctor.
Ask a doctor before use if you have
- had heartburn over 3 months. This may be a sign of a more serious condition.
- frequent wheezing, particularly with heartburn
- unexplained weight loss
- nausea or vomiting
- stomach pain
Ask a doctor or pharmacist before use if you are
- taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Stop use and ask a doctor if
- your heartburn continues or worsens
- you need to take this product for more than 14 days
- you need to take more than 1 course of treatment every 4 months
- you get diarrhea
- you develop a rash or joint pain
If pregnant or breast-feeding, ask a health professional before use.
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Directions
- adults 18 years of age and older
- this product is to be used once a day (every 24 hours), every day for 14 days
- may take 1 to 4 days for full effect
14-Day Course of Treatment
- swallow 1 capsule with a glass of water before eating in the morning
- take every day for 14 days
- do not take more than 1 capsule a day
- swallow whole. Do not crush or chew capsules.
- do not use for more than 14 days unless directed by your doctor
Repeated 14-Day Courses (if needed)
- you may repeat a 14-day course every 4 months
- do not take for more than 14 days or more often than every 4 months unless directed by a doctor
- children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.
Other Information
- read the directions and warnings before use
- keep the carton. It contains important information.
- Store at 20° to 25°C (68° to 77°F).
Questions or comments?
Call toll-free weekdays 9 AM to 6 PM EST at 1-888-721-7115.
Product of India
Additional Information
Do Not Use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" or Blue band around the center of each capsule is broken or missing.
Tips for Managing Heartburn
- Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
- Eat slowly and do not eat big meals.
- Do not eat late at night or just before bedtime.
- Do not lie flat or bend over soon after eating.
- Raise the head of your bed.
- Wear loose-fitting clothing around your stomach.
- If you are overweight, lose weight.
- If you smoke, quit smoking.
Distributed by:
Glenmark Therapeutics Inc., USA
Elmwood Park, NJ 07407
Product of India
07/25
- Inactive Ingredients
-
Package/Label Principal Display Panel
Principal Display Panel - 20 mg Capsules: Container Label
NDC: 72657-127-14
Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg
Acid Reducer
Treats Frequent Heartburn
May take 1 to 4 days for full effect
24 HOURS
14 Capsules
One 14-day course of treatment
Product of India
-
Package/Label Principal Display Panel
Principal Display Panel - 42 Capsules Carton label
NDC: 73657-127-42
Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg
Acid Reducer
Treats Frequent Heartburn
May take 1 to 4 days for full effect
24 HOURS
42 Capsules
Three 14-day courses of treatment
Product of India
-
INGREDIENTS AND APPEARANCE
ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 72657-127 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength RAW SUGAR (UNII: 8M707QY5GH) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) POLYSORBATE 80 (UNII: 6OZP39ZG8H) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) TALC (UNII: 7SEV7J4R1U) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERYL DISTEARATE (UNII: 73071MW2KM) Product Characteristics Color WHITE (white opaque colored) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code 20mg;186 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 72657-127-42 3 in 1 CARTON 08/06/2025 1 14 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA216349 08/22/2023 Labeler - GLENMARK THERAPEUTICS INC., USA (969085666) Registrant - Graviti Pharmaceuticals Private Limited (650884781) Establishment Name Address ID/FEI Business Operations Graviti Pharmaceuticals Private Limited 650884781 MANUFACTURE(72657-127) , ANALYSIS(72657-127)
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